Articles Tagged withXarelto

Recently, three cases in the Xarelto multi-district litigation (MDL) ended in defense verdicts in favor of Xarelto’s manufacturers, Bayer, Janssen, and Johnson & Johnson. These lawsuits, specifically the Orr trial, the Boudreaux trial, and the Mingo trial, stem from the manufacturers’ failure to provide instructions regarding routine prothrombin time (PT) testing for patients with a high risk of bleeding while on Xarelto. In addition, the plaintiffs argued that defendants misled doctors about whether tests were available to assess effects and risks of the medicine.

Since the cases ended in verdicts for the drug manufacturer, the Plaintiffs are now appealing for new trials. The plaintiffs argue that the defense verdicts are a result of the district court wrongfully admitting evidence, denying admission of other evidence, and giving improper instructions to the jury.

In the legal brief, these arguments for new trials are broken down into four main points:

After more than three years of litigation, and with no settlement agreement in sight, Judge Eldon Fallon has issued a court ruling to move hundreds of cases along in the next several months. Just to recap, the federal court in Louisiana was chosen as the multi-district litigation (MDL) site for plaintiffs filing lawsuits for injuries suffered after taking the blood-thinning drug Xarelto. In 2017 Janssen, Bayer and Johnson & Johnson, manufacturers and sellers of Xarelto, won three “bellwether trials” in this MDL, which you can read about here. Nevertheless, studies and evidence show Xarelto can cause uncontrollable bleeding in patients, and there is no available antidote once the bleeding starts. But with the defense winning three cases last year, the drug companies have (so far) not been willing to agree to a global settlement of the remaining 21,000+ cases. In an effort to wind down the litigation and encourage settlement, Judge Fallon has chosen to move things along:

Case Management Order No. 6

On February 27, 2018, Judge Fallon issued Case Management Order No. 6 (CMO No. 6) in the Xarelto MDL. This Order sets out the procedure for the selection of 1,200 Xarelto cases over the next six months. These cases will enter rigorous individual discovery and will be prepared for trials in the plaintiffs’ home districts. Among other things, the plaintiffs chosen in these 1,200 cases will be responsible for completion of an extensive “Plaintiff Fact Sheet,” which is essentially a comprehensive questionnaire on all salient facts about the Plaintiff, the Plaintiff’s use of Xarelto, the injuries suffered, and other relevant information. The defendants will also have to submit a “Defendant Fact Sheet.”

Earlier this month the judge in the most recent Xarelto trial voided a $27.8 million jury verdict. I wrote about that case here and here and here. On January 9, 2018, Judge Michael Erdos in Philadelphia state court held that the jury’s verdict on plaintiff’s inadequate warning claim was not supported by the evidence. Let’s take a look:

Treating Doctor’s (Very Unhelpful) Testimony

One key issue in the case was whether Defendants Bayer AG, Janssen Pharmaceuticals and Johnson & Johnson failed to provide adequate warnings on the Xarelto label regarding the increased risk of internal bleeding. In an important study, bleeding rates for patients taking Xarelto in the United States were much higher than the bleeding rates of patients in other countries. This information was not added to the Xarelto label until September 2015. Plaintiff Lynn Hartman was prescribed and took Xarelto in 2013 and 2014.

Today, a jury in Philadelphia awarded approximately 28 million dollars to a woman who suffered serious gastrointestional bleeding after taking the blood-thinning drug Xarelto. It was a huge win for the plaintiff, Lynn Hartman. Ms. Hartman took Xarelto for over a year to treat atrial fibrillation. She suffered internal bleeding and was eventually hospitalized. She needed four blood transfusions. According to court documents, the internal bleeding eventually stopped, and Ms. Hartman was taken off the medication. After she stopped taking Xarelto and switched to another blood-thinner, she had no further internal bleeding.

One important witness for the plaintiff at trial was David Kessler, the former Commissioner of the Food and Drug Administration. Kessler testified that he believed the warning label on Xarelto was inadequate and lacked important information regarding the specific risks of internal bleeding.

Sadly, I’ve written about allegations of witness-tampering before. It is an awful and unethical thing, and it undermines the ability of a litigant to get a fair trial. Beyond that, it calls into question the legitimacy of our entire legal system.

Witness-tampering is an attempt by one side in a trial to influence or change the testimony of an opponent’s witness. Most of us have seen dramatizations of witness-tampering in movies and on television. Maybe the most famous cinematic depiction of witness-tampering was in Godfather, Part II, when Frank Pentangeli changed his sworn testimony in a Senate Hearing investigating Godfather Michael Corleone’s corruption and murder. Prior to Pentangeli’s testimony, Corleone flies in Pentangeli’s beloved brother from Sicily, an unmistakable message to Pentangeli that Corleone can reach anyone in Pentangeli’s family, and that no one is safe. Once the hearing begins, Frank Pentangeli changes his testimony, and he testifies that he knows nothing about the mafia or Michael Corleone, and that he gave a prior sworn statement under extreme pressure from investigators. It is a dramatic moment in the film, and the witness-tampering allows Michael Corleone to avoid findings of corruption and murder and a likely criminal conviction. You can check out that famous “witness-tampering” scene here.

In the world of product liability cases, allegations of witness-tampering are much less dramatic, but witness-tampering any case can have devastating effects. If a key witness changes his or her testimony, the case can be lost for the litigant who relied on the original evidence.

The first Xarelto trial is underway in the Philadelphia Court of Common Pleas. The cases in Philadelphia state court are separate from the federal court Xarelto multidistrict litigation situated in Louisiana. I have written about Xarelto often on this website, and you can read more about the medication and the lawsuits that followed here. The cases in the Court of Common Pleas are very similar to the MDL cases, and most of the cases involved allegations of uncontrollable internal bleeding. The Philadelphia state court mass tort program has been taking Xarelto cases since 2014, and currently there are more than 1,500 cases filed there. More cases are being filed each week, in Pennsylvania and in the Louisiana MDL.

The first of these “Philadelphia cases” went to trial this week. For the plaintiffs in both state and federal court, a win would be most welcome, as plaintiffs in the first three MDL bellwether cases lost.

Medical device and prescription drug jury verdicts come rapid fire, with a few cases being tried at any given moment across the country. Below is a recap on three recent jury verdicts involving Ethicon pelvic mesh, the blood-thinning drug Xarelto, and the testosterone drug Androgel.

Pelvic Mesh (September 7, 2017)

Last week a Philadelphia jury awarded a seriously injured woman $57.1 million in damages caused by defective Ethicon TVT pelvic mesh. This was the largest verdict for a pelvic mesh lawsuit against Ethicon, Inc. and Johnson & Johnson (the parent company of Ethicon). The award included $7.1 million in compensatory damages, which encompasses pain and suffering damages, as well as a huge $50 million award for punitive damages.

Last Friday in the third Xarelto bellwether trial, a jury in Jackson, Mississippi reached a verdict in favor of defendants. The defendants have now won three straight Xarelto bellwether cases. Plainly, the defense has had a good year. But remember, the MDL judge and the executive committees selected 40 cases for discovery and consideration as bellwethers, not three. As I tell my daughter when she comes home after the third day of school and announces she doesn’t like her teacher: “It’s too soon to have an opinion. Give it more time.”

On June 12, 2017, a jury in New Orleans reached a verdict in favor of defendants in the second Xarelto bellwether trial. This verdict follows a defense verdict in the first bellwether trial. Let’s take a closer look.

The Second Xarelto Bellwether Trial

To recap briefly, Xarelto (rivaroxaban) was first approved by the FDA for sale in 2011. As an anticoagulant, it was supposed to prevent pulmonary embolism (PE), deep vein thrombosis (DVT), strokes, and other serious conditions. And it was easier to take than warfarin. In studies, however, Xarelto caused a higher rate of complications from internal bleeding; but unlike other anticoagulant drugs, there is no “antidote” for stopping internal bleeding in patients. People bleed and often can’t stop bleeding.

More than 18,000 lawsuits have been filed against the drug manufacturers of Xarelto over internal bleeding injuries. Two weeks ago the first bellwether case in the Xarelto multidistrict litigation was tried to a jury in Louisiana. On May 3, 2017, that jury rendered a verdict in favor of Bayer Healthcare Pharmaceuticals, Janssen Pharmaceuticals, and parent company Johnson & Johnson. After a seven day trial, the jury found in favor of defendants on one narrow issue: that the plaintiff did not prove his claim that the drug makers failed to give adequate instructions to the physician on the safe use of Xarelto; specifically, the plaintiff argued that drug makers failed to give instructions to doctors about the need to perform a blood-clotting test on Xarelto patients before prescribing the drug.

Although a setback for the plaintiffs, this narrow decision makes me confident there is “plenty of game left” in the overall Xarelto litigation. I do not believe the Boudreaux case adequately represents so many of the remaining claims against Bayer, Janssen, and J&J.